The 16th century English poet John Donne had famously written, “No man is an island, entire of itself.”
On Monday, U.S. Food and Drug Administration Commissioner Margaret Hamburg said that five centuries later, today’s globalized world arguably requires the words to be updated to “There are no islands.”
At a time when FDA-regulated medical imports have dramatically risen, Hamburg and other FDA officials were unveiling new strategies to ensure global product safety and quality. The FDA report entitled “Pathway to Global Product Safety and Quality” called for the following:
- FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
- The coalitions of regulators will develop international data information systems and networks, and increase the regular and proactive sharing of data and regulatory resources across world markets.
- The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
- The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
Indeed, the agency is in a difficult position just with the volume of FDA-regulated products that are coming from outside the nation’s borders. As Hamburg pointed out: 80 percent of active pharmaceutical ingredients come from overseas and a full 40 percent of drugs are imported, as are half of all medical devices.
Yet, the authority that the FDA possesses in the medical products side dates back to a 1938 law when most medical products were manufactured at home.
Still, it’s not clear whether the above strategies will have the effect the agency desires: a better system to deal with medical imports so that the border becomes a “final checkpoint.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Some of the strategies described require legislative updates — for instance sharing of data with foreign regulatory bodies. And others require the widening of FDA’s authority to the medical products side, similar to what the agency got on the food side with the passage of a historic Food Safety Modernization Act late last year.
Still, even if the agency gets the wider authority it seeks, budget battles may undermine it. Just last week, House Republicans voted to cut $205 million from the $955 million that President Barack Obama was seeking to fund the new food safety law. Republicans believe the private sector can police itself.
The issue of funding was the 800-pound gorilla in the room that the commissioner and her colleagues initially did not directly address. Later, in response to a reporter’s question, Hamburg conceded that the initiatives would “require upfront dollar resources, people resources,” but it was also evident that the agency believes that whether Congress provides the money or the authority it would need, this is the right path to be on.
“Whether we get new authority or not, we are moving ahead,” said John Taylor, acting principal deputy commissioner of food and drugs.
The confidence perhaps comes from the fact that worldwide regulators are dealing with the same thorny issue of how to keep their populations safe. The question is, are they willing to put their money where their mouths are and share some of the costs with the FDA?
